{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T06:45:25Z","timestamp":1776408325033,"version":"3.51.2"},"reference-count":21,"publisher":"Public Library of Science (PLoS)","issue":"1","license":[{"start":{"date-parts":[[2025,1,9]],"date-time":"2025-01-09T00:00:00Z","timestamp":1736380800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Purpose<\/jats:title>\n<jats:p>To evaluate prevalence and incidence rates of pigmentary maculopathy and retinopathy (PM\/PR), and visual acuity (VA) changes in patients exposed to pentosan polysulfate sodium (PPS) and in patients with interstitial cystitis (IC) not exposed to PPS.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>This is a retrospective cohort study (January 2015\u2013March 2021) which included adult de-identified patients from the American Academy of Ophthalmology IRIS\u00ae Registry (Intelligent Research in Sight) and Komodo Health database. Three patient cohorts were identified: two PPS-exposed patient cohorts, and Non-PPS-exposed IC patient cohort. Key study outcomes included PM\/PR\/Any (defined based on prior literature regardless of PPS exposure) and PM\/PR\/PPS (further defined by an algorithm that was based on clinical notes and other protocol-prespecified criteria in PPS-exposed patients), and VA changes in each respective cohort.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Prevalence of PM\/PR\/Any was relatively common in patients prior to PPS exposure (4.16%\u20138.43%). Incidence rate of PM\/PR\/PPS was uncommon in both PPS-exposed cohorts (0.13\u20130.15 per 100 person-years). Crude incidence rates of PM\/PR\/Any (based on ITT analysis) varied slightly across 3 study cohorts (2.13\u20132.81 and 2.38 per 100-person-years for PPS-exposed cohorts and Non-PPS-exposed IC cohort, respectively). Across all 3 study cohorts, patients with PM\/PR\/Any appeared to have approximately 2-fold higher proportion of 3 lines of VA worsening than those without PM\/PR\/Any.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Prevalence of PM\/PR was common in patients prior to PPS exposure. Incidence of PM\/PR\/PPS that may be associated with PPS exposure was relatively uncommon. Crude incidence rates of PM\/PR appeared similar across all patient cohorts regardless of PPS exposure.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0313497","type":"journal-article","created":{"date-parts":[[2025,1,9]],"date-time":"2025-01-09T18:29:33Z","timestamp":1736447373000},"page":"e0313497","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":1,"title":["Retrospective study of incidence\/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5824-2040","authenticated-orcid":true,"given":"Zhong","family":"Yuan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Subusola","family":"Vaughan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carolyn","family":"Jeffcoat","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Hu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ritchie","family":"Yuson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Fife","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Durga","family":"Borkar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,1,9]]},"reference":[{"issue":"2","key":"pone.0313497.ref001","doi-asserted-by":"crossref","first-page":"113","DOI":"10.5489\/cuaj.10095","article-title":"Long-term 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of sodium pentosanpolysulfate in the treatment of interstitial cystitis and related painful bladder disease","volume":"138","author":"M Holm-Bentzen","year":"1987","journal-title":"J Urol"},{"issue":"3","key":"pone.0313497.ref005","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1016\/S0090-4295(97)00714-0","article-title":"Long-term experience with pentosanpolysulfate in interstitial cystitis","volume":"51","author":"JV Jepsen","year":"1998","journal-title":"Urology"},{"issue":"1","key":"pone.0313497.ref006","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/j.urology.2007.09.013","article-title":"Time to initiation of pentosan polysulfate sodium treatment after interstitial cystitis diagnosis: effect on symptom improvement","volume":"71","author":"JC Nickel","year":"2008","journal-title":"Urology"},{"issue":"3","key":"pone.0313497.ref007","doi-asserted-by":"crossref","first-page":"845","DOI":"10.1016\/S0022-5347(17)35629-X","article-title":"A quantitatively controlled method to study prospectively interstitial cystitis and demonstrate the efficacy of pentosanpolysulfate","volume":"150","author":"CL Parsons","year":"1993","journal-title":"J Urol"},{"issue":"11","key":"pone.0313497.ref008","doi-asserted-by":"crossref","first-page":"1793","DOI":"10.1016\/j.ophtha.2018.04.026","article-title":"Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium","volume":"125","author":"WA Pearce","year":"2018","journal-title":"Ophthalmology"},{"issue":"8","key":"pone.0313497.ref009","doi-asserted-by":"crossref","first-page":"1093","DOI":"10.1136\/bjophthalmol-2019-314765","article-title":"Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort","volume":"104","author":"N Jain","year":"2020","journal-title":"Br J Ophthalmol"},{"issue":"6","key":"pone.0313497.ref010","doi-asserted-by":"crossref","first-page":"835","DOI":"10.1016\/j.ophtha.2020.01.017","article-title":"Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy","volume":"127","author":"RA Vora","year":"2020","journal-title":"Ophthalmology"},{"issue":"11","key":"pone.0313497.ref011","doi-asserted-by":"crossref","first-page":"2891","DOI":"10.1007\/s00192-021-04970-0","article-title":"Pentosan associated retinal pigmentary changes: FDA\u2019s perspective on an emerging postmarketing safety finding.","volume":"32","author":"A Lardieri","year":"2021","journal-title":"Int Urogynecol J"},{"issue":"11","key":"pone.0313497.ref012","doi-asserted-by":"crossref","first-page":"1275","DOI":"10.1001\/jamaophthalmol.2019.3392","article-title":"Phenotypic Spectrum of Pentosan Polysulfate Sodium-Associated Maculopathy: A Multicenter Study.","volume":"137","author":"AM Hanif","year":"2019","journal-title":"JAMA 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maculopathy.","volume":"2009","author":"PP Connell","year":"2009","journal-title":"J Ophthalmol"},{"issue":"3","key":"pone.0313497.ref020","doi-asserted-by":"crossref","first-page":"219","DOI":"10.1016\/j.oret.2021.07.004","article-title":"Expanded Clinical Spectrum of Pentosan Polysulfate Maculopathy: A Macula Society Collaborative Study.","volume":"6","author":"N Jain","year":"2022","journal-title":"Ophthalmol Retina."},{"issue":"2","key":"pone.0313497.ref021","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1016\/j.jcjo.2019.12.001","article-title":"Pentosan-associated maculopathy: prevalence, screening guidelines, and spectrum of findings based on prospective multimodal analysis","volume":"55","author":"D Wang","year":"2020","journal-title":"Can J Ophthalmol"}],"container-title":["PLOS 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